Medicinal Plants and Herbal Remedies

Medicinal Plants, Natural Products and
Phytotherapy: Introduction
(2 h 4 slots)
Michael Heinrich
Centre for Pharmacognosy
and Phytotherapy
UCL School of Pharmacy,
29 - 39 Brunswick Sq.,
London, WC1N 1AX, UK
Waterhouse Pharmacy, Southgate
London

Availability of complementary medicines for
retail sale in pharmacies in England (1998)
99% sell at least one type of
complementary medicine,
including vitamins/minerals
92% sell at least one type of
complementary medicine,
excluding vitamins and minerals
IPSOS /Mori 2009, Barnes J, Abbot NC.
Pharm J 1999;263:R37,R43
Waterhouse Pharmacy, Southgate London
Why is it important ?

3
Why are respondents
attracted to herbal remedies?
(N=307).
Online Survey 2018 (UK):
about herbal medicines.
Survey responses were
categorised and analysed
using Qualtrics
408 participants (numbers
varied across questions)
Herbal medicines are
popular, particularly amongst
the 36 to 55 year old age
group.
Used herbal medicines for
minor-self-limiting conditions.
UK: Herbal Medicines. Who Cares?
Lazarou and Heinrich 2019 Phytother. Res.
people use natural products
→ seems to be natural
→ seems to have less side effects
→ considered to be effective
we are supposed to help
with these situations:
↳ Sleep
↳
anxiety
↳ Stress
↳ immune system booster
↳ Survey highlight what people
do → patients care alot about
products .

4
Use herbal remedies for groups of
health conditions (N=324) -
multiple answers possible
Online Survey 2018 (UK):
about herbal medicines.
Survey responses were
categorised and analysed
using Qualtrics
408 participants (numbers
varied across questions)
popular, particularly amongst
the 36 to 55 year old age
group.
Used herbal medicines for
minor-self-limiting conditions.
§ Patient care
a lot

5
"In general, herbal remedies are
effective for minor health
conditions" (N=144)
"In general, herbal remedies
are effective for major health
conditions" (N=144)
↳ patients in this survey are
very clear about herbal medicine
→ herbal medicines have Place
for minor conditions
(
""" " " "
herbal medicines
may
help but
maybe
not .

6
Lazarou & Heinrich 2019 Phytother. Res.
Main plants
used in healthcare
→
used for
inflammatory
conditions
&
topically for
some conditions
and also
internally
&
gastrointestinal
problems

7
Response No. selecting
this answer
% of
Participants
64 21.1
I trust the supplier 30 9.9
I see if it works 49 16.1
Packaging 5 1.6
Smell, colour and taste 23 7.6
THR 10 3.3
Research 27 8.9
Using suppliers that use good manufacturing
practice (GMP)
7 2.3
Brand reputation 31 10.2
Reviews/ word of mouth 37 12.2
1
How do you know if a herbal product is of good or bad
quality (N=304)
↳ most p¥ttient doriot know how to assess the
quality of product .

8
Response No. selecting
this answer
% of
Participants
64 21.1
I trust the supplier 30 9.9
I see if it works 49 16.1
Packaging 5 1.6
Smell, colour and taste 23 7.6
THR 10 3.3
Research 27 8.9
Using suppliers that use good manufacturing
practice (GMP)
7 2.3
Brand reputation 31 10.2
Reviews/ word of mouth 37 12.2
1
How do you know if a herbal product is of good or bad
quality (N=304)
Informal interviews showed that
people were unaware of how
poor the quality of some products
are on the market, which could
perhaps be why THR was so
lowly valued.

Do people tell their doctor of pharmacists about using
traditional remedies? (British Indian)
0
10
20
30
40
50
60
70
80
90
Doctor Pharmacist
Number
of
participants
Yes
No
Not applicable
Of the total research population, 106 participants who took
prescribed medication were asked if they told their doctor or
pharmacists about the concurrent use of traditional remedies.
Telling healthcare professionals?
Bhamra et al
2019.
Phytotherapy
Research
↳ If people are on diverse
medications
↳ would Patient tell pharmacist
that
they are
taking herbal
medicine.
↳
very few patients tell would
tell doctor and even few of
their pharmacists
that
they are
taking herbal
meds.

Community pharmacists need to be aware of the methods
for quality control and standardisation, the differences in
quality, and, of course, should promote high quality
products which very often also have many clinical studies
to back up the therapeutic claim(s)
Pharmaceutical analysis is a core skill of pharmacists and
particular attention needs to be paid to
phytopharmaceutical quality
All pharmacists need to be aware of the use of herbal
reported in our recent survey that they had used CAM in
the last 12 months. This usage then needs to be assessed
and not just disregarded as quackery or ignored because it
is natural.
Further reading: Heinrich, M., J. Barnes, J. Prieto-Garcia,
S. Gibbons and E.M. Williamson (2018) Fundamentals of
Pharmacognosy and Phytotherapy. 3rd ed. London.
Churchill Livingston (Elsevier) Edinburgh. (Chapter 10; or
chapter 9 in the 2nd ed.)

Pharmacognosy
Derived from pharmakon gignosco,
(Greek)
The science of biogenic or nature-derived pharmaceuticals and
poisons
Focuses on all medicinal plants, including those yielding
- complex mixtures, which are used in the form of crude
herbs or extracts [(rational) phytotherapy]
- pure compounds such as morphine, and
- foods having an additional health benefits (health food /
nutraceuticals).
Natural products
Natural products = small molecular weight organic compounds of natural
origin [plants, microbes (fungi and bacteria), marine organisms and more
exotic sources such as frog skins and insects] inthe molecular weight
range of 100 2000 Daltons (Da).
In the context of pharmacognosy, natural products are looked at
regarding their biological origin, extraction [or (semi-)synthetic
production], pharmacology, clinical use and role in drug discovery
study
of medicines or crude
drugs
produced from natural resources such
as plants ,
animals
,
microbes .
→ if it has evidence based
→
commonly used not to treat a disease but prevention of
disease.
→
mostly plant derived
They isolate the products . we look from the product has come from
,
as well as
the process
y
↳ Natural products are Important
↳ look at them from the perspective of fwhere they come from
,
how they are processed ,
How we get
the pure compound and how we do structure identification of
these
compounds .

Registered traditional herbal medicines THMP
(Traditional Herbal Medical Product Directive)
This regulatory framework has been in place for over 15
years and regulates the uses (claims), quality and safety of
herbal medical products sold as OTC medicines
Any manufactured herbal medicine placed on the market
under Section 12 (2) of the Medicines Act since 30 April
2004 need to comply with the requirements of the scheme.
It is relevant for any product which
- Makes a medical claim (treatment or
prevention of an illness) (or)
- Is sold in a form which implies that it is used
medicinally (and)
- Can only be used for minor self-limiting
diseases and generally as an OTC product
Herbal Medicines traditional
use OTC medicines
Symbol given by
} MHRA
µ
e. g ↳ common cold
↳ GI Problems
↳ milder form of
depression called
low mood.
&
logo

This regulatory framework has been in place for well over
ten years and regulates the uses (claims), quality and
safety of herbal medical products sold as OTC medicines
Any manufactured herbal medicine placed on the market
under Section 12 (2) of the Medicines Act since 30 April
2004 need to comply with the requirements of the scheme.
It is relevant for any product which
- Makes a medical claim (treatment or
prevention of an illness) (or)
- Is sold in a form which implies that it is used
medicinally (and)
- Can only be used for minor self-limiting
diseases and generally as an OTC product
use OTC medicines

Key requirements
- The products are approved by the MHRA and fully
regulated
- The use is based on 30 years of traditional use (of which
15 have to be within the European Union)
- Mostly OTC products (an on the general sales list GSL)
- Produced under GMP (Good Manufacturing
Practice)
- For minor self-limiting diseases only
- Only for products which are considered to be
(very) safe
- A full Patient Information Leaflet (PIL)
approved by the MHRA must be included
-
use OTC medicines

Key requirements (continued)
- Defined recommended dose and usage
- The pharmaceutical producer must conduct weekly
updates esp. with regards to safety (database searches)
- The therapeutic use must be plausible
- The product name is included in Braille on the box
- The MHRA regularly monitors the product
- They are medicines and as such YOU,
as a pharmacist, will have the professional
responsibility (as with all other medicines)
- You can recommend and sell these products
and need to give preference to THR
products vs. unregulated ones
- Most products now carry the THR logo
use OTC medicines
→
what you
should take e.g
how
many tablet
*
e.g
respiratory problems
at problems
p
if it is in Braille
then it's a THR
Product
* ↳ must be completely
y
under Pharma co
violence
so
If
any concerns
they win raise it with producer

Main therapeutic uses of THR products
based on an EU-wide assessment
Most common products have been registered under the
THR to treat cough / cold, mental stress / mood disorders
and gastrointestinal complaints
Peschel 2014
This is
basically derived from data
relating to what
products on the market.

framework:
herbal medicines (1968)
Product Licences of Right (PLRs) granted to all existing
products when Medicines Act came into force (1968)
At PLR review, traditional herbal medicines used for minor, self-limiting
conditions were permitted to draw on bibliographic evidence of efficacy
and safety rather than carry out controlled tests and trials product
licence (PL number); now generally moved under the THR scheme
Section 12 of Medicines Act 1968 provides two crucial
exemptions from licensing for herbal medicines:
treatment
(2) herbs only subjected to simple processing, sold under
common/botanical name, no written uses
without direct medical claims (> 5000?)
Only regulated herbal medicines are required to comply with
regulatory provisions on quality and pharmacovigilance
-
Patient
might
get
medication
e
] Chinese / European herbalist → give meds to patient prepared on the premises for the treatment at home
herbal
so
only
with THR logo win actually require to comply with regulatory provisions and 7

Other elements of the regulatory framework
European Pharmacopoeia with > 240 monographs on herbal drugs
EU directive 65/65/EEC (now 2001/83) - medicinal product
(definition):
"Any substance or combination of substances presented for
treating or preventing disease in human beings or animals".
"Any substance or combination of substances which may be
administered to human beings or animals with a view to
making a diagnosis or to restoring, correcting or modifying
physiological functions in human beings or animals is likewise
considered a medicinal product".
i.e. medicinal by presentation OR function
applies to herbal products just the same as to other products
greater flexibility on use of bibliographic data to demonstrate
safety and efficacy
but interpretations varied between member states; not widely
applicable to wide range of unregulated herbal products

Medicines registered under the
THR (Traditional Use Directive)
Safety
Quality
Traditional
use
↳ medicines those which are
medicine derived from
Plants
normally registered
under traditional use
directive for THR
↳ The evidence which is
derived from traditional
use
substituting tie
efficacy
based on
clinical studies
↳ traditional use implies
evidence for commeri.cat
product with a similar
chemical composition
having been on the
market in europe for
at least 30 years.

Quality and safety of licensed
herbal medicines
Safety
Quality
Clinical
evidence for
efficacy
must show

Herbal Medical
products and pure
natural products (used
as medicines)

Herbal medicines are chemically rich
complex mixtures
Aspirin tablets
contain:
Aspirin
(excipients)
wort
herb contain:
Hyperforin, adhyperforin, hypericin,
pseudohypericin, isohypericin, protohypericin,
protopseudohypericin, kaempferol, quercetin,
luteolin, hyperoside, isoquercitrin, quercitrin,
rutin, biapigenin, amentoflavone, catechins,
tannins, other phenols etc etc
(excipients)
contains whole range
p of natural product,
individual compounds
/

Pure Natural Products
vs. Herbal Preparations
Herbal preparations /
phytomedicines
A complex mixture of active
and inactive compounds
generally derived from plants
Definition of actives and
preferably standardisation
Are legally considered to be
medicinal products and/or
health food supplements
May be registered or licensed
Chemically defined
biogenic drugs
One or very few active
substances derived from
natural sources
----
Medicinal products
Generally licensed
↳
quality control
moynot be linked to the
actives
↳
may be linked to
something you
can detect easily.
p
They ✓ &
↳ it is important to know which compound make an Important contribution
to
activity
THRS
9
and

Production and quality are
linked intrinsically
Plants and fungi yield both
- pure natural products
like morphine
- herbal medical products
(registered) and food
supplements
→ Produced in large
quantities
↳ In Both cases quality
control of this herbal substance
is very Important

From plant to patient:
Pure compounds as medicines
The botanical starting material:
The living plant
Botanical Drugs
Extraction / Isolation /
Purification / Formulation
Use by patients
A multi-step
process resulting
in chemically
defined medicines
↳ If looking
at a pure compound like morphine
↳ Then you
need to understand the botanical
starting materials that live in plant
↳ How it grows
↳ need to understand botanical drug
how it is processed potentially
isolated ,
purified and then
formulated
into a medicine
herbal medicine
↳ the process is similar but main difference
is in third step
↳ living plant, quality assurance ,
have botanical drugs
and then have extractions formulation into
mixture of compounds called Phytochemicals.

Herbal medicines
The living plant
Botanical Drugs
(Extraction) Formulation
into Phytomedicines
Use by patients
Often a
simple formulation /
generally resulting in
chemically complex
products

Extract (Definition)
European Pharmacopoeia (2002, chapter 01/2002-
765): an extract is a concentrated preparation of
liquid (fluid extract or tinctures) or intermediate
(semi-liquid) or solid (dry extract) consistency
normally produced from dried botanical or
zoological material by a technique involving the use
of adequate solvents for obtaining a mixture of
compounds.
For some preparations, the material to be extracted
may undergo a preliminary treatment prior to
extraction (e.g. de-fatting, inactivation of enzymes
or most commonly simply grinding).
See Fundamentals of Pharmacognosy and Phytotherapy

Standard*
Reference
SJW
%
Sample
1
2
3
4
5
6
7
* - pure compounds as a reference
% - reference US Pharmacopoeia
Regulated products (1 7)
Hypericum perforatum regulated
products vs. unregulated products
Hypericum perforatum (
products regulated (THR) products have
a consistent composition (but may vary in
strengths) based on a TLC comparison
Two examples of
unregulated products
(often from the internet)
show a tremendous
variability and
adulteration including the
use of food dyes to trick
quality control schemes

previous page explanation
Akin z;⇐÷÷÷•
and consistent chemical profile
n

Globally used as a herbal
medical product (licensed /
registered) or supplement.
Large unregulated market
(internet)
Mainly produced in China,
Southern America and parts of
Europe
31
Ginkgo biloba unregulated supplements
HPTLC-based analysis
Note the enormous
differences in the
with rutin
https://www.bbc.co.uk/programmes/articles/4hX30rMYkMv9YjMTH38MY6/do-herbal-supplements-contain-what-
they-say-on-the-label

↳ Most supplements are
unregulated
↳
it is used for cognitive decline in the
elderly
↳ it is also used for some other specific syndromes
↳ The 35 Samples looks all the same but
they are
different
↳
Unregulated herbal medicine products cannot be dispensed by pharmacies because we have concerns about the
quality and
safety
↳ it is a TLC which helps to first separated than visualised individual compounds found in the specific
plant .

Globally used as a herbal
medical product or
supplement.
Large unregulated market
(internet)
Mainly produced in China,
Southern America and parts of
Europe
32
Ginkgo biloba unregulated supplements
HPTLC-based analysis
Note the enormous
differences in the
with rutin
Often
Intentional
Unregulated herbal medical
products cannot be dispensed
by pharmacists
https://www.bbc.co.uk/programmes/articles/4hX30rMYkMv9YjMTH38MY6/do-herbal-supplements-contain-what-
they-say-on-the-label

Herbal
Medical
Products
(HMPs)

Botanical Drugs
Botanical drug, defined as
dried parts of entire plants,
plant organs, or parts of
plant organs for use as
medicines, aromatics,
spices or excipients
used in the production of pharmaceuticals or
Isolated products directly obtained from plants which no
longer have an organ structure, such as essential and fatty
oils, balsams etc.
Botanical drugs also are the basis for the isolation of pure
natural products the production of herbal medicines (e,g
herbal teas and for the production of extracts used for
phytomedicines Picture from Wichtl et al 2004
↳ Comes from
speific plant
↳ You would proceed called
essential oil extraction
fused
for
→ tooth
ache
→ tooth
decay
2
Clove is
very helpful
in
dentistry →
useful
antiseptic

A wide range of herbal medicinal products is
available to patients
Wide range of preparations
available:
Crude herbs often sold by
herbalists / in TCM shops
Extracts (today the main range)
Formulations / dosage forms
Solid dosage forms: tablets,
capsules
Semisolid: creams, ointments
Liquid dosage forms: tinctures
etc
Combination preparations:
several herbs (multiherb);
herb-vitamin/mineral products
Image from European Herbal Practitioners
Association website
fused
for bruises
and other external
applications
→ regulated
]→ unregulated
→ not controlled at some standard as above product
→ it is
legal to sell this but it is quite important to know whether takes
these prescription given by TCM practitioner

A wide range of herbal medicinal products is
available to patients
Wide range of preparations
available:
Crude herbs often sold by
herbalists / in TCM shops
Extracts (today the main range)
Formulations / dosage forms
Solid dosage forms: tablets,
capsules
Semisolid: creams, ointments
Liquid dosage forms: tinctures
etc
Combination preparations:
several herbs (multiherb);
herb-vitamin/mineral products
Image from European Herbal Practitioners
Association website
Fully
registered
medicines
Unlicensed

Some top-selling herbal medical products (HMPs)
Hypericum perforatum
Valerian (valeriana officinalis)
Echinacea (Echinacea angustifolia)

↳ used in
management
of common cold ,
mild form of
↳ mild
,
moderate form of depression or low mood
few •
←
Induce sleep
help people
who are
restless
p
inflammatory Back pain

A large number of fully
regulated (THR and some
licensed) products are
available and can be
dispensed with great
confidence.

Traditional herbal medicines registered under the THMPD
(examples): Single ingredient products some examples
Common
name
Botanical name Registered Products
Agnus castus
fruit
Vitex agnus-castus L. Premherb Tablets
Arnica
flowerheads
Arnica montana L. Atrogel Arnica Gel
Black Cohosh
root / rhizome
Cimicifuga racemosa (L.)
Nutt.
Menoherb Tablets
root
Harpagophytum
procumbens D.C. and/or H.
zeyheri L. Decne.
tablets
Flexiherb Tablets
Based on Linda Anderson, MHRA
↳ common used in
premenstrual syndrome
↳ topically Put on unbroken skin to treat inflammatory skin
conditions
↳ menopausal
symptoms-
Chronic
↳ pain
condition
specially
inflammatory
conditions

Plant Derived Pharmaceuticals: General
Features 1
Derived from herb (aerial parts), leaves, fruits, seeds,
roots/rhizome (or other underground organs), bark or
other parts of a (higher) plant
material, they may be sold as such or as an extract
Most of these products are on the GSL (General Sales
List), some are P only (Pharmacy only) or POM
(Prescription only medicines), see above
Herbal medicines (and the botanical drugs the are
derived from) are generally made up of complex
mixtures of natural products, some of these are the
active compounds, others are considered to be of little
of no pharmacological relevance (This is an essential
difference to other pharmaceuticals).

what are the unique pharmaceutical features
↳ you need to define where within the plant
it comes from
↳ need to be clear what plant part it is
↳ it can be aerial part of the leaves
↳ Then important to know whether it is fresh or
dry plant materials
↳ herbal medicine are made of complex mixture of natural products of
individual compounds
→ some are active compounds
→ others are little or no
pharmacological relevance
↳ NOT
selling pure compounds ars costs are too
high .

Plant Derived Pharmaceuticals:
General Features 2
Product derived from a plant and transformed into a
drug by drying certain plant parts or sometimes the
whole plant or
Product obtained from plants, which no longer retains
the structure of the plant or its organs but which
contains a complex mixture of biogenic compounds
(e.g. fatty and essential oils, gums, resins, balms)
Isolated, pure natural products like the numerous
nature-derived pharmaceuticals used in pharmacy are
thus not a botanical drug, but a chemically defined
drug derived from nature.
In the context of pharmacy a botanical drug is a
See Fundamentals of Pharmacognosy and Phytotherapy Chapters 10 and 11

From plants to medicines
Living plant
Botanical drug
Herbal medical product /
phytomedicine
Processing
(incl. extraction)
Drying
Botanical name and family
Plant parts used in pharmacy
(botanical drug)
Botany
Legal category (UK)
Monographs (e.g. Eur.
Pharmacopoeia)
Phytotherapeutic (and other)
uses
Chemistry
Pharmacology and
toxicological risk
µ
↳
is it a THR or not
↳ is it a ash or not
so what are the active
natural product in it
p
benefit

Herbal Drug
(Often Drying, Grinding),
Extraction:
Herbal Drug Preparation
Drying and Processing
Formulation Formulation
Herbal
Medical
Product
Chemical
a
pharmacological
ont
2 type of extracts
^
nine
drug material is then extracted
extracts are more effective in
treating specific conditions

What do we need to know about a
phytomedicine
Botanical origin (species and family)
Plant part which provides the drug
Type of product used as a phytomedicine with a specific
health claim:
- Ground plant material,
- Uncharacterised extract,
- Standardised extract,
- Processed (special) extract
Active constituents
(if known)
Pharmacological effects and clinical effectiveness, side
effects and interactions with other (botanical) drugs
Lower pharmaceutical quality
Higher pharmaceutical quality
e-
g
need to know if plants has a certain active compounds .
it is useful to know
what active compound actually is

The living plant
Botanical Drugs
Extraction / Isolation /
Purification / Formulation
Dispensing
The living plant
Botanical Drugs
(Extraction) Formulation
into Phytomedicines
Uncontrolled sale
or Dispensing
Use by patients Use by patients
Herbal medicines Pure natural
(phytomedicines) products as medicines
The pharmaceutical process is often similar for both groups, and the main
differences are in the chemical complexity of the final products and until
recently in the uncontrolled status of many (but not all) herbal medicines
! *
! *
p
morphine
-
extraction of
morphine is
"" " " " "
?⃝
results in extracted
a mixture
as a
mixture
of
compounds
and then
purified
this than is
and dispensed
formulated
into a
under
very carefully
defined conditions
Phyto medicine
↳ sad in an
uncontrolled was
or
↳ dei rented based on your own
assement of the Patient

Herbal Medical
Products
Some
examples
Or:
What do you
need to know
about these
products
Extractor for herbal medical products,
W. Ransom, Hitchin, UK
you put the plant material in and the solvent
and
you boil it and then the solvent with extract
is removed and dried and further processed

A herbal drug needs to be defined
precisely, as have to be the
medicines derived from it
- Plant species
- Plant part used
- Extraction
- Processing
-
}
}A medical product*
* - or a supplement

Quality assessment of extracts
Extracts are often characterized by the drug:solvent
ratio (DSR), which gives the relationship of the amount
of drug extracted to the volume of solvent (e.g. 1:10)* -
most commonly used
The drug-extract ratio (DER), on the other hand, gives
information on the amount of extract obtained from a
botanical drug: 4 : 1 (maceration, 70% ethanol). In this
case 4 units (e.g. kg) of a drug yield 1 unit of dried
extract. This DER is often given as a range (e.g. 3 5)
and always in whole numbers.
An extract prepared from (dried) drug material using
defined solvent systems is processed into a variety of
pharmaceutical products (e.g. tablets for crude
extracts).
* -
e-
g.
DER =
give info about the HABEAS
amount OF extract obtained ↳
extracted
from a botanical
drug
e-
9 4 :| → 4 units of drug
with 1 unit of
botanical drug

An example of a medicinal drug: Cloves 1
Botanical name: Syzygium aromaticum (L.)
Merr. et L. M. Perry
Family: Myrtaceae (Myrtle family)
Plant parts used in pharmacy: the unripe flower
buds, also clove oil is used
Botany: derived from an evergreen tree native
Indonesia), but now widely cultivated, the
flower buds are particularly rich in essential oil

The flowering parts of the
plant Syzygium
aromaticum - Cloves Tree
The botanical drug:
Cloves
↳ Contact dermatitis -
Inflammation side effects

Chemistry: The most important compound is eugenol
(C10H12O2) a simple phenylpropane-derivative.
Pharmacology: Eugenol - Effective antiseptic and
bactericidal compound
Toxicological Risk: Clove oil is stated to be a membrane
irritant, to cause contact dermatitis and others, the drug
not be taken in doses greatly exceeding those used in
food. In Jan 2008 some concerns have been raised about
the toxicological risk of high doses of clove oil in babies
(based on a case of a 15 months old boy who developed
hepatitis after the oil was used (in a high concentration)
for teething problems.
problem was not the oil but ppl administering it got the dose
wrong so they used
inappropriately
high dose.

Turmeric (Curcumae domesticae rhizoma) 1
Turmeric is the subject of much current
research but detailed clinical evidence is
lacking so far.
The plant and the drug: Curcuma domestica Val.
(syn. C. longa L.) (Zingiberaceae)
Rhizomes dark yellow powder with a characteristic
taste and odour.
Spice and colouring agent
A related species - Javanese turmeric (Curcuma
xanthorrhiza Roxb., Curcumae xanthorrhizae rhizoma
Ph. Eur.), mostly used for dyspepsia and other
gastrointestinal problems.
↳ +
used for
travel sickness

Constituents
Curcuminoids; the mixture known as curcumin, consisting of
several phenolic diarylheptanoids, including curcumin,
monodemethoxycurcumin and bisdemethoxycurcumin
An essential oil (about 3-5%), containing about 60%
sesquiterpene ketones (turmerones), including arturmerone,
alpha-atlantone, zingberene; with borneol, alpha-phellandrene,
eugenol and others
Polysaccharides such as glycans, the ukonans A-
CH3O
HO CH CH CO CH C
OH
CH CH
OCH3
OH
µ
active groups
of constituent
←
it is not
extracted
but instead
used in
this
mixture

Pharmacological effects and clinical efficacy
Extract (turmeric):
- Protects against stomach ulcers in rats
- Antispasmodic effect
- Hypoglycaemic (in vivo in animals)
- hypocholesterolaemic effects (both in animal and
human clinical studies
- Immunostimulant activity, due to the polysaccharide
fraction,
- anti-asthmatic effects have been noted, together with
anti-mutagenic and anticarcinogenic effects.
- Antibacterial and antiprotozoal in vitro
Example of an issue often encountered in natural
product pharmacology: strong effects but on multiple
targets
Toxicology: Turmeric is well tolerated (spice).
Cf. Fundamentals of Pharmacognosy and Phytotherapy
→ not a registered product but it is one
repeatedly used food supplement

Hypericum perforatum L.)
24.6.
Traditional uses
- Nervous afflictions: excitability,
menopausal neurosis, hysteria,
nervousness, anxiety, depression,
and as a nerve tonic
Clinically well-validated uses: Symptomatic relief of mild to moderately
severe depression (low mood), topically for wound healing
- see workshop -
Physiological nerve disorders: sciatica, neuralgia, spinal
injuries
- External use: oily preparations for wounds, bruises,
swellings, shingles
p
traditional uses are excitability ,
mild -
moderately
depression.

An example of a phytomedicine:
Harpagophyti radix -
The plant and the drug
Derived from Harpagophytum procumbens DC
(Pedaliaceae)-
Fairly recently developed into a successful and
relatively well-characterised medicine which is
monographed in the Ph. Eur.
Botanical drug: The secondary storage roots currently only
collected in the savannahs of southern Africa (South Africa
and Namibia, mainly the Kalahari desert), while still fresh,
cut into small pieces and dried.
Obtained from the wild (gathered), but attempts are
underway to cultivate it.
Traditional uses (Africa) -
bladder problems.
↳ used for back pain

See Fundamentals of Pharmacognosy and Phytotherapy p. 152 and 263-4,
Plant part used medicinally: Rootstock
(Foto W. Caesar, Stuttgart, DE)
p
desert plants
grows very slowly
→ depends on
rainfall
so hard to 0 btai

Harpagophytum zeyerhi, another species
common in southern Africa - considered
to be an adequate substitute. It contains
similar natural products as H. procumbens.
Historical uses (Europe), a tea (made from a dose of
about 1.5g/day of the powdered drug) for the
treatment of dyspeptic disorders such as indigestion
and lack of appetite ( bitter glycosides).
Most pharmacological and clinical
research has, however, been conducted
using standardised extracts for the
treatment of rheumatic conditions and
lower back pain as well as other
degenerative conditions of the
musco-skeletal system (see below).
BP
and
EP

Relevant Natural Products
Bitter iridoids, harpagide
and harpagoside, with
8-O-p-coumaroylharpagide,
procumbide -O-p-coumaroyl-
procumbide and procumboside.
Phenylethyl-glycosides like
verbascoside and isoacteoside.
Especially the iridoids are
currently considered to be of
pharmacological importance
although research continues.
According to the Eur. Ph. the drug must contain 1.2%
harpagide and harpagoside, expressed as harpagoside.
Analysis is by HPLC.
O
OH
HO
H
OGlc
HO
O
OH
HO
H
OGlc
O
O
HO
OH
O
O
CH2OH
HO
O
O
HO
HO
OH
O
O
OH
OH
Harpagide Harpagoside
Verbascoside (a marker substance)
(active substances)
am ,
analytically • i
µ
not pharmacologically
active
they have become
marker substances
to assess the
quality
Simple terpenoids → composed of 5) 10,1520 carbons Here
you have mono terpenoids = TO 10 Carbons + a glycoside

Production of botanical drugs
Most important medicinal plants are today produced
under controlled agricultural conditions
Differences in quality may be due to:
- Temperature and annual course of temperature
- Rainfall (if it is not possible to irrigate the fields)
- Soil characteristics and quality
- Day length and sun characteristics
-
These require detailed studies for each species to
be cultivated.
Often the production is based on the principles of
GMP (Good Manufacturing Practice) and or ISO-
certification, in this case GAP (Good Agricultural
Practice) and the subsequent processing steps
(drying, cutting, grinding, storage, packaging,
transport etc., which are covered by GMP).
Note
most widely used medicine
Plants are produced on a controlled agricultural conditions .
So impact on
quality can be controlled to some extent .

European Pharmacopoeia:
Regulations for Botanical Drugs
Title (English name, Latin name used in international
trade)
Definition of the drug (plant part to be used; whether
it is fresh, dried, cut or powdered, and possibly also
specifying constituents typical for the drug, with
minimal amounts required)
Characters - Organoleptic or other properties of the
drug (smell, colour, other similar characteristics, and
rarely, taste (not usually included in the European
Pharmacopoeia for reasons of safety)
↳ trying to find good quality products

European Pharmacopoeia:
Regulations for Botanical Drugs
Identification (macroscopic and microscopic
description, and in some cases TLC- characteristics)
Tests for purity (providing data on maximum amounts
of foreign matter, i.e. non-acceptable substances, loss
on drying, ash)
Required level of biologically active or lead
compounds
Storage (general information about required forms of
storage)
See Fundamentals of Pharmacognosy and Phytotherapy Chapter 10,
cannot store a botanical drug in human environment as it will
get
moulded

Quality of botanical drugs
Numerous specific requirements exist for
assuring appropriate quality of botanical
drugs and extracts:
- Botanical identity (Species and drug)
- Purity [max. level of other (botanical)
material]
- Moisture levels (bot. drug only)
- Pesticides (maximum)
- Microbial contaminants (maximum)
- .... (many things might go wrong)
what level of other
botanical material is
allowed

Microbiological Contamination
The maximum number of micro-organisms allowed is
regulated in the European Pharmacopoeia (for details
see Eur. Phar. 2002 -chapter 2.6.12):
up to 105 aerobic micro-organisms per g or ml,
including
- up to 103 yeast and fungi per g or ml and
- up to 103 enterobacteria per g or ml
no detectable Escherichia coli [in 1 g or ml]
no detectable Salmonella sp. [in 10g or ml] (Franz
1999).
(see Fundamentals of Pharmacognosy and Phytotherapy)
↳ why microbiological
contamination is important
→ because we start with living plant material
→ that means there will be host for range
of microorganism
→ we will define Max amount of yeast and
fungi
→ we define intra bacteria
→ we
try to avoid C- -
coli and salmonella species both of them are crucial ones which may
lead
to health detect

Microbiological Contamination
Specific requirements for storage and transportation
of the drug have to be met
In many cases this is now controlled via GAP
(Good Agricultural Practise) and GMP (Good
Manufacturing Practise) standards
Similar requirement relates to microbial
contamination of botanical drugs. Each natural
material naturally harbours a large number of
spores and other micro-organisms.
See Fundamentals of Pharmacognosy and Phytotherapy
Good agriculture ,
storage , Processing practise
I must be complied with .
so have whole series
Of standards which must be complied with Ethan
labelled as GMP ,practise .
This
in cooperates importantly ways
to prevent spores and other
microorganisms from
entering
the material.

Conclusion:
In order to advise patients
you need to understand
the chemical composition /
quality and production of
a herbal medical product
(and this is all based on the
herbal regulations)

Third edition
2018
2015 (1st ed.)

Medicinal Plants and Herbal Remedies

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